UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of olfactory stimulation derived from foods on mood and body temperatures: a randomized cross-over trial.
Title of the study (Brief title)	Effects of olfactory stimulation derived from foods on mood and body temperatures.
Region	Japan

Condition
Condition	Adult
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the changes in mood and body temperatures after olfactory stimulation with foods in young women.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Awakening/sleepiness scores - resting condition - during olfactory stimulation - immediately after stimulation
Key secondary outcomes	Body temperatures Warm sensation Autonomic nervous system activities

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Olfactory stimulation using liquid with normal concentration -> Wash out -> Control (olfactory stimulation using mineral water) - single administration - 10 ml of sample - 65-min stimulation
Interventions/Control_2	Control (olfactory stimulation using mineral water) -> Wash out -> Olfactory stimulation using liquid with normal concentration - single administration - 10 ml of sample - 65-min stimulation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	25 years-old >
Gender	Female
Key inclusion criteria	1) Japanese women 2) Age >=20 years, <25 years 3)Good health conditions determined by the health examination in April 2015 4) Less than 2 kg body weight change within the past one month 5) Having a regular menstrual cycles 6) Informed consent provided
Key exclusion criteria	1) Pregnancy, breast-feeding, or planning a pregnancy 2) Received the medical treatment for hypertension/diabetes/dyslipidemia/heart disease or gastric ulcer 3) During medication 4) Had the excessive fatigue or stress within one month 5) History of smoking 6) Difficulty to determine the smell due to otolaryngology diseases 7) No alcohol tolerance 8) Subjects judged by the project leader to be ineligible for other reasons
Target sample size	12

Research contact person
Name of lead principal investigator	Narumi Nagai
Organization	University of Hyogo
Division name	School of Human Science and Environment
Address	1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan
TEL	+81-79-292-1515
Email	nagai@shse.u-hyogo.ac.jp

Public contact
Name of contact person	Narumi Nagai
Organization	University of Hyogo
Division name	School of Human Science and Environment
Address	1-1-12 Shinzaike-honcho, Himeji, Hyogo, 670-0092 Japan
TEL	+81-79-292-1515
Homepage URL
Email	nagai@shse.u-hyogo.ac.jp

Sponsor
Institute	University of Hyogo
Institute
Department

Funding Source
Organization	Suntory Grobal innovation Center Ltd. (the sample supplier)
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Suntory Grobal innovation Center Ltd.
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	兵庫県立大学環境人間学部（兵庫県）（School of Human Science and Environment, University ofHhyogo, Hyogo-prefecture)

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 12 Day
Anticipated trial start date	2016 Year 03 Month 26 Day
Last follow-up date	2016 Year 05 Month 01 Day
Date of closure to data entry	2016 Year 10 Month 01 Day
Date trial data considered complete	2016 Year 12 Month 01 Day
Date analysis concluded	2017 Year 03 Month 31 Day

Related information
URL releasing protocol	https://www.jstage.jst.go.jp/article/jsnfs/71/5/71_243/_article/-char/ja
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/jsnfs/71/5/71_243/_article/-char/ja
Results
Other related information

Management information
Registered date	2016 Year 03 Month 26 Day
Last modified on	2019 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024943